Notice2025-14223
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35684-35685]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14223]
[[Page 35684]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0418]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tropical Disease
Priority Review Vouchers
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 28, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0822. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#742426352700151212341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="acfcfeedffd8cdcacaeccac8cd82c4c4df82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tropical Disease Priority Review Vouchers
OMB Control Number 0910-0822--Extension
This information collection supports implementation of statutory
requirements as discussed in Agency guidance. Section 524 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360n) is
designed to encourage development of new drug or biological products
for prevention and treatment of certain tropical diseases affecting
millions of people throughout the world and makes provisions for
awarding priority review vouchers for future applications to sponsors
of tropical disease products. Section 524 of the FD&C Act serves to
stimulate new drug development for drugs to treat a ``tropical
disease'' (as defined in section 524(a)(3)) by offering additional
incentives for obtaining FDA approval for pharmaceutical treatments for
these diseases. As defined in section 524(a)(4) of the FD&C Act, a
sponsor of a ``tropical disease product application'' may be eligible
for a voucher that can be used to obtain a priority review for any
other application submitted under section 505(b)(1) of the FD&C Act (21
U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (PHS
Act) (42 U.S.C. 262).
Accordingly, we developed the procedural guidance document
entitled, ``Tropical Disease Priority Review Vouchers'' (October 2016),
(available at <a href="https://www.fda.gov/media/72569/download">https://www.fda.gov/media/72569/download</a>). The guidance
document explains how FDA implements provisions of section 524 of the
FD&C Act and how sponsors may qualify for a priority review voucher
based on eligibility criteria set forth in the statute, how to use
priority review vouchers, and how priority review vouchers may be
transferred to other sponsors. The guidance also communicates that
section 524 of the FD&C Act requires attestation by the sponsor of
eligibility for a priority review voucher upon submission of the
marketing application.
Description of Respondents: Sponsors submitting applications under
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.
In the Federal Register of May 1, 2025 (90 FR 18680) we published a
60-day notice soliciting comment on the proposed collection of
information. Comments received supported that the collection of
information provided utility to FDA and encouraged its continued use.
The comments also suggested FDA consider a broader scope of information
collection and greater use of technological submission mechanisms. We
appreciate all comments and are committed to making enhancements to our
collection systems as our limited resources allow. At the same time,
the comments suggested no adjustment in FDA's estimate of burden for
the information collection.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Reporting under section 524 of the FD&C Act Number of responses per annual burden per Total
respondents respondent responses response hours
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Priority Review Voucher Request.............. 1 1 1 8 8
Notifications of Intent To Use a Voucher..... 2 1 2 8 16
Letters Indicating the Transfer of a Voucher 1 1 1 8 8
Letter......................................
Acknowledging the Receipt of a Transferred 1 1 1 8 8
Voucher.....................................
Attestation of Eligibility................... 1 1 1 2 2
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Total.................................... ........... .............. ........... ........... 42
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 35685]]
Based on our evaluation of the information collection since the
last OMB review and approval, the burden estimate decreased based on
receipt of fewer vouchers and other information collection activities.
Our estimated burden for the information collection reflects an overall
decrease of 46 hours and a decrease of 8 responses.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14223 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
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